The present invention relates to the field of blood sampling, specifically in the area of blood glucose monitoring to help ensure adequate levels of capillary blood are collected for a glucose test.
Diabetes is a disease, which affects a large segment of the population. According to the American Diabetes Association (ADA), it is estimated that nearly 16 million people in the Unites States have diabetes. Today, however, approximately half of this figure or 8 million people have been diagnosed with the disease.
People with diabetes, in order to maintain their blood glucose in a "normal" range, must balance their level of exercise, their diet and their medication (insulin). In order to monitor an individual's effectiveness in maintaining these variables, an individual must measure their blood glucose up to 4 or more times per day. The tool that provides these individuals with a snapshot of their glucose level, and hence, a measurement of how well these variables are being balanced or managed, is the blood glucose monitor.
Self-monitoring of blood glucose (SMBG) was made possible during the late 1970's through the introduction of slow, technique dependent glucose meters. These glucose meters have since undergone significant improvement. Today, blood glucose meters are capable of providing a blood glucose reading in less than 30 seconds, are the size of a fountain pen and are relatively simple to use.
The technological advances in blood glucose meters and the increased awareness of the importance of maintaining glycemic control in avoiding the complications associated with diabetes have led to a dramatic increase in the number of individuals using blood glucose meters. Today, approximately 4 million individuals use blood glucose meters in the United States which equates to approximately 1.3 billion tests annually.
Despite the numerous technological advances over that past fifteen years, many user problems have not been satisfactorily addressed in regard to SMBG. In particular, many individuals still have difficulty obtaining an adequate blood sample from their finger tip required to effectively measure their blood glucose level. This difficulty can result from fingers being calloused from repeated testing and poor circulation, amongst other factors.
Once a blood sample is obtained, the sample is then transferred to a reagent coated test "strip" that works in combination with the glucose meter. When small blood samples are obtained due to inability to harvest a large enough blood sample, the test strips are frequently wasted and/or the glucose meter will give an inaccurate result. The fingerstick is so problematic in executing effective blood glucose measurement that there are currently over 75 initiatives worldwide being pursued to address or eliminate this problem. Complications in obtaining a blood sample are increased as a normal progressive side effect of the disease and also as the individual naturally ages.
Finally, while numerous prior devices have attempted to address blood collection using traditional large scale tourniquet-type devices, these prior efforts have failed to produce a simple, elegant solution that is low in cost, easy to use with a single hand, and which is especially adapted for use in obtaining blood samples from a smaller extremity such as a fingertip.